Genetic Engineering & Biotechnology News

OCT1 2012

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.

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ADVERTORIAL Corporate Capabilities DSM Biologics O Innovative World of Biopharmaceutical Manufacturing ur main focus is to create brighter lives for people today and for gen- erations to come. With more than 25 years of experience in contract manufacturing, DSM Biologics has the essential expertise and drive to help our customers in their mission to save human lives. DSM offers dedicat- ed mammalian contract manufacturing services, and by using a variety of technologies we manu- facture our customer's new generation drugs for treatment of incurable diseases, e.g., various types of cancer and autoimmune diseases. Flexibility and innovation is the main driving force in meeting our customers' expectations. Challenging conventional process technologies with innovation and forward-looking solutions leads us to the next generation of manufacturing processes—leaner and more efficient. Our state-of-the-art facility, located in Gron- ingen, The Netherlands, is dedicated to the de- velopment, scale-up, and cGMP manufacturing of recombinant proteins and monoclonal anti- bodies. The Groningen facility has consistently been successful when inspected by European and U.S. regulatory authorities. In order to meet the global needs of our customers, DSM Biologics is currently expanding its manufacturing capabil- ity into a new geographic area. Our new facility for cGMP manufacture of biopharmaceuticals will be open in 2013 in Brisbane, Australia. Markets DSM Biologics 45 Waterview Boulevard Parsippany, NJ 07054-1298 Phone 973.257.8220 Email info.dsmbiologics@dsm.com Website www.dsmbiologics.com Date Founded 1986 Number of Employees 160 Experienced with a global customer base, DSM Biologics provides manufacturing technol- ogies and services to the worldwide biopharma- ceutical market. Being in the industry for more than a quarter of a century, the company has adapted its services to the needs of our custom- ers and to evolving challenges in the biopharma- ceutical market. Today we partner with small, medium, and large pharmaceutical and biotech- nology companies, and support them with con- tract manufacturing services from the earliest stage of development, through clinical trials and to full commercial supply. Capabilities DSM Biologics offers state-of-the-art facili- ties and contract manufacturing expertise to our customers, and delivers the right quantity and quality of biopharmaceutical products within the agreed customer timelines. Our service portfolio includes manufacture of therapeutic recombinant proteins, monoclonal antibodies, fusion proteins, and antibody fragments. Our Groningen plant is designed to address all of our customer needs. The plant comprises process development and cGMP facilities of ~20,000 ft2 (~1,860m2 ) each. The cGMP area contains suites with 50 L, 250 L, 500 L, and 1,000 L single-use and stainless steel bioreactors, as well as several DSP suites equipped with fil- tration devices (dead-end, cross-flow filtration) and all of the necessary types of chromatography operation (resins or membrane). Commercial production will begin in 2013 in a new Brisbane, Australia, facility. DSM Biologics provides a full range of analytical development capabilities as well as regulatory support to all customers. DSM Biologics' unique position in being able to utilize innovative and superior process technologies, like the proprietary XD® bust® and Rho- technologies (above), makes the company a sought-after technology provider. The XD technology is a highly inten- sified cell culture process, that provides cells with a constant environment for optimal cell growth. The XD technol- ogy works in a continuous media feeding mode, with a filtration unit to retain both the cells and the recombinant protein in the bioreactor (right). The process is ro- bust and scalable, while still maintaining consistent product quality. This revolu- tionary technology for mammalian cell culture results in 5- to 15-fold increases Genetic Engineering & Biotechnology News in titers compared to the original process. Rhobust technology is a second generation expanded bed adsorption (EBA) technology that works as a direct capture in the cell separation unit operation, by combining clarification and product capture into one single step. Centrifuga- tion, depth-filtration, and packed bed chromatog- raphy can be replaced by one unit operation, re- sulting in less preparation and process time, lower cost of goods, and reduced investment costs. In addition, product recovery and purity are equally good or better to classical process approaches. We invite you to hear more about the excit- ing innovations and services available at DSM Biologics by emailing info.dsmbiologics@dsm. com or calling 973-257-8220 for a personal follow-up from our team. Q | genengnews.com | October 1, 2012 | 69

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